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US 11,026,908 B2Granted
Extended release dosage forms of pregabalin
AssigneeMapi Pharma Ltd.
InventorsYoram Sela, Shai Rubnov
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AssigneeMapi Pharma Ltd.
InventorsYoram Sela, Shai Rubnov
Estimating the term…
The present invention relates to extended-release pharmaceutical compositions comprising pregabalin or a salt thereof, which are adapted to release the pregabalin active ingredient according to a dual release profile. The formulations comprise two components, the first (fast ER) providing extended-release of the active ingredient in a short controlled manner lasting from about 4 to about 6 hours, and the second (slow ER or maintenance) providing extended release of the active ingredient over a period of 24 hours. The proportion of each component in the formulation may be adjusted to achieve the desired AUC and therapeutic effect following oral administration to a subject. The invention further relates to methods of using the pharmaceutical compositions for treating conditions and disorders which are responsive to pregabalin treatment, such as neuropathic pain associated with diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), epilepsy, seizures and fibromyalgia.
An oral, extended-release (ER) pharmaceutical composition comprising as an active ingredient pregabalin or a salt thereof and a pharmaceutically acceptable carrier or excipient, wherein the composition comprises a first component that provides pH independent controlled release of the pregabalin active ingredient over a time period of about 4 to about 6 hours, and a second component that provides pH independent controlled release of the pregabalin active ingredient over a time period of about 24 hours,
An oral, extended-release (ER) pharmaceutical composition comprising as an active ingredient pregabalin or a salt thereof and a pharmaceutically acceptable carrier or excipient, wherein the composition comprises a first component that provides pH independent controlled release of the pregabalin active ingredient over a time period of about 4 to about 6 hours, and a second component that provides pH independent controlled release of the pregabalin active ingredient over a time period of about 24 hours,
An oral, extended-release (ER) pharmaceutical composition comprising as an active ingredient pregabalin or a salt thereof and a pharmaceutically acceptable carrier or excipient, wherein the composition comprises a first component that provides pH independent controlled release of the pregabalin active ingredient over a time period of about 4 to about 6 hours, and a second component that provides pH independent controlled release of the pregabalin active ingredient over a time period of about 24 hours,
An oral, extended-release (ER) pharmaceutical composition comprising as an active ingredient pregabalin or a salt thereof and a pharmaceutically acceptable carrier or excipient, wherein the composition comprises a first component that provides pH independent controlled release of the pregabalin active ingredient over a time period of about 4 to about 6 hours, and a second component that provides pH independent controlled release of the pregabalin active ingredient over a time period of about 24 hours,
Dependencies are inferred from the claim text.